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Biorapid

Rapid Bioprocess Development

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

Biorapid project word cloud

Explore the words cloud of the Biorapid project. It provides you a very rough idea of what is the project "Biorapid" about.

scientists drugs times recombinant cutting integral efficacy progress science medicines employing tools medicine stages validation bio quality stage business manufacturing slow characterisation efficient 15 training ing biosimilars bioprocess esrs molecule cheap treatment big industry model framework brings rapid monitoring despite regulatory biomanufacturing competitiveness applicable experts potency reducing compounds bioactive entrepreneurship education translational unavailability innovation treatments itn limits pharmaceutical medicinal patients driver external impacted diabetes personalised qbd academic principles trials clinical pharma regenerative critical molecules cells industrialist oncology realised trained timeframes pat suitably pluripotent edge demonstrated market stem therapeutic bioactives combining fundamental proteins analytical

Project "Biorapid" data sheet

The following table provides information about the project.

Coordinator	UNIVERSITY OF NEWCASTLE UPON TYNE Organization address address: KINGS GATE city: NEWCASTLE UPON TYNE postcode: NE1 7RU website: http://www.ncl.ac.uk/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	United Kingdom [UK]
Project website	http://www.bio-rapid.eu/
Total cost	4˙038˙971 €
EC max contribution	4˙038˙971 € (100%)
Programme	1. H2020-EU.1.3.1. (Fostering new skills by means of excellent initial training of researchers)
Code Call	H2020-MSCA-ITN-2014
Funding Scheme	MSCA-ITN-ETN
Starting year	2015
Duration (year-month-day)	from 2015-01-01 to 2018-12-31

Partnership

Take a look of project's partnership.

#	participants	country	role	EC contrib. [€]
1	UNIVERSITY OF NEWCASTLE UPON TYNE UNIVERSITY OF NEWCASTLE UPON TYNE Organization address address: KINGS GATE city: NEWCASTLE UPON TYNE postcode: NE1 7RU website: http://www.ncl.ac.uk/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (NEWCASTLE UPON TYNE)	coordinator	819˙863.00
2	DANMARKS TEKNISKE UNIVERSITET DANMARKS TEKNISKE UNIVERSITET Organization address address: ANKER ENGELUNDSVEJ 1 BYGNING 101 A city: KGS LYNGBY postcode: 2800 website: www.dtu.dk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (KGS LYNGBY)	participant	580˙163.00
3	LINKOPINGS UNIVERSITET LINKOPINGS UNIVERSITET Organization address address: CAMPUS VALLA city: LINKOPING postcode: 581 83 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (LINKOPING)	participant	527˙318.00
4	RISE ACREO AB RISE ACREO AB Organization address address: BOX 1070 city: KISTA postcode: 164 25 website: www.acreo.se contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	SE (KISTA)	participant	527˙318.00
5	TECHNISCHE UNIVERSITAT BERLIN TECHNISCHE UNIVERSITAT BERLIN Organization address address: STRASSE DES 17 JUNI 135 city: BERLIN postcode: 10623 website: www.tu-berlin.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (BERLIN)	participant	498˙432.00
6	CHR. HANSEN A/S CHR. HANSEN A/S Organization address address: BOEGE ALLE 10-12 city: HOERSHOLM postcode: 2970 website: www.chr-hansen.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DK (HOERSHOLM)	participant	290˙081.00
7	ALCYOMICS LTD ALCYOMICS LTD Organization address address: BULMAN HOUSE REGENT CENTRE city: NEWCASTLE UPON TYNE postcode: NE3 3 LS website: www.alcyomics.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (NEWCASTLE UPON TYNE)	participant	273˙287.00
8	FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED FUJIFILM DIOSYNTH BIOTECHNOLOGIES UK LIMITED Organization address address: BELASIS AVENUE city: BILLINGHAM postcode: TS23 1LH website: www.fujifilmdiosynth.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (BILLINGHAM)	participant	273˙287.00
9	SANOFI-AVENTIS DEUTSCHLAND GMBH SANOFI-AVENTIS DEUTSCHLAND GMBH Organization address address: BRUNINGSTRASSE 50 city: FRANKFURT AM MAIN postcode: 65929 website: www.sanofi.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (FRANKFURT AM MAIN)	participant	249˙216.00

Map

Project objective

Reducing lead times of new medicinal drugs to the market by reducing process development and clinical testing timeframes is a critical driver in increasing European (bio)pharmaceutical industry competitiveness. Despite new therapeutic principles (e.g. the use of pluripotent stem cells, regenerative medicine and treatments based on personalised medicine or biosimilars) or regulatory initiatives to enable more efficient production, such as Quality by design (QbD) with associated Process Analytical Technology (PAT) tools , the slow progress in the development of new bioactive compounds still limits the availability of cheap and effective medicines. In addition, the competitiveness of European (bio)pharma industry is impacted by the unavailability of suitably trained personnel. Fundamental changes in the education of scientists have to be realised to address the need for changes in the traditional ‘big pharma’ business model and the focus on ‘translational medicine – more early stage clinical trials with patients, more external innovation and more collaboration’ . These changes in education should be based on combining cutting-edge science from the early stage of product development through to manufacturing with innovation and entrepreneurship as an integral part of the training. The Rapid Bioprocess Development ITN, employing 15 ESRs, brings together industrialist and academic experts with its main aim to address this critical need by developing an effective training framework in rapid development of novel bioactive molecules from the very early stages of potency and efficacy testing to the biomanufacturing process characterisation and effective monitoring. The main focus of the research is on oncology related proteins and recombinant proteins to be used in diabetes treatment, although the resulting monitoring and modelling methods will be applicable to other bioactive molecule process development as demonstrated by validation on a range of relevant bioactives.

Deliverables

List of deliverables.
Two complete case studies (i) a manufacturing system for recombinant biopharmaceutical, and (ii) a manufacturing system for a drug compound	Documents, reports	2020-01-21 11:30:51
Oscillation effect/product quality methodology tested on model system	Other	2020-01-21 11:30:51
Immune/media sensors tested in industrial conditions	Documents, reports	2020-01-21 11:30:51
Soft sensor system developed and tested in industrial conditions	Documents, reports	2020-01-21 11:30:51
PhD theses complete	Documents, reports	2020-01-21 11:30:51
DoE and optimal design validated on industrial case study	Demonstrators, pilots, prototypes	2020-01-21 11:30:51
Modelling framework for rapid screening of toxicity/immunogenicity of bioactives	Other	2020-01-21 11:30:51
PAT system design under uncertainty: practical validation on a lab-scale recombinant yeast fermentation	Documents, reports	2020-01-21 11:30:51
DoE and optimal design tested on a model system	Other	2020-01-21 11:30:51
Population heterogeneity methodology tested on model system	Other	2020-01-21 11:30:51
Overall framework for rapid screening, process development and monitoring	Documents, reports	2020-01-21 11:30:51
General framework for data representation with small batch numbers, across process scales	Documents, reports	2020-01-21 11:30:51
Rapid bioprocess development strategy for diverse biomolecule structures	Documents, reports	2020-01-21 11:30:51
Methodology to investigate population heterogeneity formulated	Documents, reports	2020-01-21 11:30:50
BioRapid mid-term and final conferences	Other	2020-01-21 11:30:49
Methodology to investigate oscillation effects on product quality	Documents, reports	2020-01-21 11:30:50
Framework for PAT system design under uncertainty	Other	2020-01-21 11:30:50
Dissemination plan formally approved	Documents, reports	2020-01-21 11:30:50
Report on the most appropriate modelling methods for prediction of processing routes	Documents, reports	2020-01-21 11:30:50
Report on most appropriate modelling approaches for the general bioprocess monitoring framework	Documents, reports	2020-01-21 11:30:50
Two soft sensors adapted to impurity control of chromatography	Documents, reports	2020-01-21 11:30:49
Predictive models for the behaviour of two bioactive molecules in response to processing conditions	Documents, reports	2020-01-21 11:30:50
Report on appropriate modelling methodologies for soft sensor development for model process of partners	Documents, reports	2020-01-21 11:30:50
Project website and webinar/e-seminar software setup	Other	2020-01-21 11:30:49

Take a look to the deliverables list in detail: detailed list of Biorapid deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2018	Robert Spann, Jens Glibstrup, Klaus Pellicer-Alborch, Stefan Junne, Peter Neubauer, Christophe Roca, David Kold, Anna Eliasson Lantz, GÃ¼rkan Sin, Krist V. Gernaey, Ulrich KrÃ¼hne CFD predicted pH gradients in lactic acid bacteria cultivations published pages: , ISSN: 0006-3592, DOI: 10.1002/bit.26868	Biotechnology and Bioengineering	2020-01-21
2018	Robert Spann, Christophe Roca, David Kold, Anna Eliasson Lantz, Krist V. Gernaey, GÃ¼rkan Sin A probabilistic model-based soft sensor to monitor lactic acid bacteria fermentations published pages: 49-60, ISSN: 1369-703X, DOI: 10.1016/j.bej.2018.03.016	Biochemical Engineering Journal 135	2020-01-21
2019	Kizhedath, A., Karlberg, M., Glassey, J Cross interaction chromatography based QSAR model for early stage screening to facilitate enhanced developability of monoclonal antibody therapeutics published pages: , ISSN: 1860-6768, DOI: 10.1002/biot.201800696	Biotechnology Journal	2020-01-21
2018	Emmanuel Anane, Annina Sawatzki, Peter Neubauer, Mariano Nicolas Cruz-Bournazou Modelling concentration gradients in fed-batch cultivations of E. coli Â -Â towards the flexible design of scale-down experiments published pages: , ISSN: 0268-2575, DOI: 10.1002/jctb.5798	Journal of Chemical Technology & Biotechnology	2020-01-21
2016	Guerra, A, von Stosch, M, Glassey, J Supervision Modelling Framework for Bioprocesses published pages: , ISSN: , DOI:	Bioprocess XIII	2020-01-21
2018	Arathi Kizhedath, Simon Wilkinson, Jarka Glassey Applicability of Traditional In Vitro Toxicity Tests for Assessing Adverse Effects of Monoclonal Antibodies: A Case Study of Rituximab and Trastuzumab published pages: 30, ISSN: 2073-4468, DOI: 10.3390/antib7030030	Antibodies 7/3	2020-01-21
2016	Konakovsky, V, McCreath, G, Glassey, J Which scale down model heuristics should we use in ambr bioreactors? published pages: , ISSN: , DOI:	Bioprocess UK XIII	2020-01-21
2016	Karlberg, M, von Stosch, M, McCreath, G, Glassey, J Early Bioprocess development using PAT approaches published pages: , ISSN: , DOI:	ESBES	2020-01-21
2016	Kizhedath, A, Wilkinson S, Glassey J Early toxicity prediction using hybrid-based modelling published pages: , ISSN: , DOI:	Biorpocess UK XIII	2020-01-21
2018	Karlberg, M, Glassey, J: Exploiting mAb structure characteristics for a directed QbD implementation in process development published pages: , ISSN: , DOI:	ESBES Conference proceedings	2020-01-21
2016	Kizhedath A, Solovyova A, Glassey J Detecting the Aggregation of Antibodies by Analytical Ultracentrifugation published pages: , ISSN: , DOI:	Bioprocess XIII	2020-01-21
2018	Kizhedath, A, Wilkinson, S, Glassey, J Hybrid modelling approaches for early stage screening of monoclonal antibodies based on safety for rapid mAb developability published pages: , ISSN: , DOI:	ESBES Conference proceedings	2020-01-21
2015	Konakovsky, V, McCreath, G and Glassey J Data augmentation of high-throughput bioprocesses by rapid streamlining algorithms published pages: , ISSN: , DOI:	Biorpocess XII	2020-01-21
2017	Karlberg, M, von Stosch, M, Glassey, J Exploiting mAb structure characteristics for a directed QbD implementation in process development published pages: , ISSN: , DOI:	WCCE	2020-01-21
2018	Konakovsky, V, McCreath, G, Glassey, J Using machine learning tools in bioprocess scale up when the number of batches is small published pages: , ISSN: , DOI:	AICHE	2020-01-21
2018	Arathi Kizhedath, Simon Wilkinson, Jarka Glassey Assessment of hepatotoxicity and dermal toxicity of butyl paraben and methyl paraben using HepG2 and HDFn in vitro models published pages: , ISSN: 0887-2333, DOI: 10.1016/j.tiv.2018.12.007	Toxicology in Vitro	2020-01-21
2018	Guerra AC, Glassey J. Machine learning in biopharmaceutical manufacturing published pages: 62-65, ISSN: 1360-8606, DOI:	European Pharmaceutical Review 23(4)	2020-01-21
2018	Konakovsky, V, Andersen, M.G, Tajsoleiman, T, McCreath, G, KrÃ¼hne, U, Glassey, J. CFD in single-use bioreactors support scale-up in mammalian cell culture published pages: , ISSN: , DOI:	ESBES Conference proceedings	2020-01-21
2017	Kizhedath, A, Wilkinson, S, Glassey, J. Early adverse-effect prediction using hybrid-based modelling published pages: , ISSN: , DOI:	WCCE	2020-01-21
2016	Kizhedath, A, Wilkinson, S, Glassey, J Early toxicity prediction using hybrid-based modelling published pages: , ISSN: , DOI:	ESBES	2020-01-21
2018	Kizhedath, A, Wilkinson, S, Glassey, J Early stage adverse effect prediction for rapid screening and developability of monoclonal antibody therapeutics using a hybrid modelling framework published pages: , ISSN: , DOI:	British Toxicology Society	2020-01-21
2018	Glassey J Bioprocess development: moving through the scales with more confidence published pages: , ISSN: , DOI:	Bioprocessing European Summit	2020-01-21
2016	Konakovsky, V, Sully, S, Slingsby, F, McCreath, G, Glassey, J Scale down model characterization using Ambr 250 and SUB published pages: , ISSN: , DOI:	BPI Europe	2020-01-21
2016	Kizhedath, A, Wilkinson, S, Glassey, J Early toxicity prediction using hybrid-based modelling published pages: , ISSN: , DOI:	EuroQSAR	2020-01-21
2017	Kizhedath, A., Glassey, J: The importance of critical quality attributes in Quality by Design for rapid bioprocess development strategies published pages: 48-50, ISSN: 1360-8606, DOI:	European Pharmaceutical Review 22(6)	2020-01-21
2017	Konakovsky, V, McCreath, G, Glassey, J An industrial perspective on using ambr as scale down models in mammalian cell culture published pages: , ISSN: , DOI:	ESACT	2020-01-21
2017	Micael Karlberg, Moritz von Stosch, Jarka Glassey Exploiting mAb structure characteristics for a directed QbD implementation in early process development published pages: 957-970, ISSN: 0738-8551, DOI: 10.1080/07388551.2017.1421899	Critical Reviews in Biotechnology 38/6	2020-01-21
2016	Konakovsky, V, McCreath, G and Glassey J: Accelerated bioprocess characterization by data enrichment in scale-down models published pages: , ISSN: , DOI:	Cell Culture Engineering	2020-01-21
2016	Guerra, A, von Stosch, M, Glassey, J M3C in Mammalian Cell Cultures: Data Pre-processing Methods published pages: , ISSN: , DOI:	ESBES	2020-01-21
2017	Karlberg, M, Kizhedath, A., von Stosch, M, Wilkinson, S, Glassey J Exploiting mAb structure characteristics for rapid screening and a directed QbD implementation in process development published pages: , ISSN: , DOI:	ACS Biot	2020-01-21
2018	Kizhedath, A, Wilkinson, S, Glassey, J Assessment of hepatotoxicity and dermal toxicity of butyl paraben and methyl paraben using HepG2 and HDFn in vitro models published pages: , ISSN: , DOI:	British Toxicology Society	2020-01-21
2018	Guerra, A, Dalton, J, Glassey, J Soft-sensor platform for biopharmaceutical development and manufacturing published pages: , ISSN: , DOI:	ESBES Conference proceedings	2020-01-21
2018	Martin KÃ¶gler, Andrea Paul, Emmanuel Anane, Mario Birkholz, Alex Bunker, Tapani Viitala, Michael Maiwald, Stefan Junne, Peter Neubauer Comparison of timeâ€gated surfaceâ€enhanced raman spectroscopy (TGâ€SERS) and classical SERS based monitoring of Escherichia coli cultivation samples published pages: 1533-1542, ISSN: 8756-7938, DOI: 10.1002/btpr.2665	Biotechnology Progress 34/6	2020-01-21
2016	Christian Bach, Robert Spann, Hilde Larsson, Ines Larsson, Mads Orla Albaek, Krist V. Gernaey, Ulrich KrÃ¼hne Computational Fluid Dynamics - en genvej til procesindsigt published pages: 14-17, ISSN: , DOI:	Dansk Kemi 10, 2016	2020-01-21
2017	Emmanuel Anane, Diana C. LÃ³pez C, Peter Neubauer, M. Nicolas Cruz Bournazou Modelling overflow metabolism in Escherichia coli by acetate cycling published pages: , ISSN: 1369-703X, DOI: 10.1016/j.bej.2017.05.013	Biochemical Engineering Journal	2020-01-21
2016	Arathi Kizhedath, Simon Wilkinson, Jarka Glassey Applicability of predictive toxicology methods for monoclonal antibody therapeutics: status Quo and scope published pages: , ISSN: 0340-5761, DOI: 10.1007/s00204-016-1876-7	Archives of Toxicology	2020-01-21
2016	Patricia Roch, Carl-Fredrik Mandenius On-line monitoring of downstream bioprocesses published pages: 112-120, ISSN: 2211-3398, DOI: 10.1016/j.coche.2016.09.007	Current Opinion in Chemical Engineering 14	2020-01-21

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